Idera Pharmaceuticals Reports Fourth Quarter and Full Year 2012 Financial
Results and Provides Update on Autoimmune Disease Program
Business Wire
CAMBRIDGE, Mass. -- March 11, 2013
Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) today reported its financial and
operational results for the fourth quarter and year ended December 31, 2012.
“During the past year, Idera has demonstrated promising clinical activity for
the use of Toll-like Receptor antagonists as a novel approach for the
potential treatment of autoimmune diseases,” said Sudhir Agrawal, D.Phil.,
Chairman and Chief Executive Officer. “We recently completed dosing in the
escalating single-dose portion of our Phase 1 study of IMO-8400, an antagonist
of TLRs 7, 8 and 9. In this portion of the trial, IMO-8400 was well-tolerated
and showed TLR target engagement at three dose levels in healthy subjects.
These results build on the results of our Phase 2 clinical trial of IMO-3100,
an antagonist of TLRs 7 and 9, in patients with plaque psoriasis, which we
believe provided clinical proof of concept of our approach of targeting
specific TLRs for the treatment of psoriasis and other autoimmune and
inflammatory diseases.”
Dr. Agrawal continued, “Our next step is to conduct a Phase 2 clinical trial
in patients with psoriasis with an extended treatment period of up to 12
weeks. Based on our evaluation of the comparative profiles of IMO-3100 and
IMO-8400, including the engagement of TLR8 by IMO-8400, Idera has determined
to conduct this Phase 2 trial with IMO-8400. Subject to successful completion
of our ongoing multiple dose Phase 1 trial of IMO-8400 and to obtaining the
necessary financing to conduct this trial, we expect to initiate this Phase 2
clinical trial in the second quarter of 2013.”
“Our 2012 year-end cash and cash equivalents totaled $10.1 million. We are
exploring financial alternatives to obtain the additional capital to continue
progress with our autoimmune disease program,” said Mr. Lou Arcudi, Senior
Vice President of Operations and Chief Financial Officer.
Financial Results
As of December 31, 2012, cash and cash equivalents totaled $10.1 million
compared to $24.6 million at December 31, 2011.
Fourth Quarter Results
Net loss applicable to common stockholders for the three months ended December
31, 2012 was $6.5 million, or $0.24 per diluted share, compared to net loss
applicable to common stockholders of $9.7 million, or $0.35 per diluted share,
for the same period in 2011. There was no significant revenue recognized in
the fourth quarter of 2012 or 2011. Research and development expenses for the
three months ended December 31, 2012 totaled $3.1 million compared to $5.7
million for the same period in 2011. General and administrative expenses for
the three months ended December 31, 2012, totaled $1.3 million compared to
$1.5 million for the same period in 2011.
Full Year Results
Net loss applicable to common stockholders for the year ended December 31,
2012 was $22.5 million, or $0.81 per diluted share, compared to net loss
applicable to common stockholders of $28.3 million, or $1.03 per diluted
share, for 2011. Total revenues in each of the years ended December 31, 2012
and 2011 were $0.1 million. Research and development expenses for the year
ended December 31, 2012 totaled $13.7 million compared to $18.0 million for
2011. General and administrative expenses for the year ended December 31, 2012
totaled $6.3 million compared to $7.9 million for 2011.
2012 Research and Development Highlights
Autoimmune and Inflammatory Diseases Program
Idera’s approach to the potential treatment of autoimmune and inflammatory
diseases involves inhibiting the induction of immune responses mediated
through TLR7, TLR8 and TLR9. These TLRs are known to be activated in
autoimmune and inflammatory diseases by aberrant complexes that contain host
RNA or DNA. The Company has two TLR antagonist drug candidates in clinical
evaluation.
IMO-8400 is an antagonist of TLR7, TLR8 and TLR9.
Phase 1 Single Ascending Dose Trial in Healthy Subjects Completed
During the first quarter of 2013, the Company completed the escalating
single-dose portion of a Phase 1 trial of IMO-8400 in healthy subjects.
The Company initiated the Phase 1 clinical trial of IMO-8400 in the fourth
quarter of 2012 to assess the safety and the pharmacodynamic activity of
IMO-8400 in healthy subjects. The single-dose portion of this trial involved
three escalating dose levels of 0.1, 0.3, and 0.6 mg/kg of IMO-8400, or
placebo with six subjects receiving each treatment, and was completed during
the first quarter of 2013. IMO-8400 treatment was well tolerated at all dose
levels, and the intended target engagement of TLR7, TLR8, and TLR9 was
observed in IMO-8400 treated subjects compared to placebo-treated subjects.
The Company commenced the multiple-dose portion of this trial in the first
quarter of 2013. The multiple-dose portion of this trial involves two dose
levels of IMO-8400, 0.3 and 0.6 mg/kg, and placebo, with six subjects
receiving each treatment of four weekly doses. The Company expects data from
the multiple-dose portion of this trial to be available in the second quarter
of 2013.
Next Steps in Clinical Development
The next step in the Company’s autoimmune and inflammatory diseases program is
to initiate a Phase 2 clinical trial of IMO-8400 in patients with plaque
psoriasis with a treatment period of up to 12 weeks. In the planned Phase 2
trial, 32 patients will be randomized to receive weekly doses for up to 12
weeks of IMO-8400 at one of three dose levels or placebo. Safety and
improvement in Psoriasis Area Severity Index (PASI) score will be monitored
throughout the study. The Company anticipates initiation of the study during
the second quarter of 2013. In March 2013, a protocol for the trials was
submitted to the regulatory authorities in Europe for review. The Company also
expects to initiate a Phase 2 clinical trial of IMO-8400 in patients with
lupus during the second half of 2013. Both trials are subject to successful
completion of the ongoing multiple dose Phase 1 trial of IMO-8400 and to the
Company obtaining the necessary financing to conduct the trials.
Pre-clinical studies and presentations
Dr. James G. Krueger, M.D., Ph.D., of The Rockefeller University, gave an oral
presentation entitled “Novel Toll-like Receptor Antagonists Strongly Decrease
Expression of IL-23-induced and Psoriasis Profile Genes in a Mouse Model” in
the Late-Breaking Research Symposium on March 2^nd, 2013, during the American
Academy of Dermatology Annual Meeting. Dr. Krueger presented data showing
that, in a preclinical model of IL-23-induced skin inflammation, genes related
to the production of key mediators of psoriasis including Interleukin (IL)
-17, IL-6, IL-12/23, IL-1, IL-21 Receptor, and INF-gamma were restored toward
normal levels by treatment with IMO-3100 and IMO-8400. The inclusion of TLR8
activity with IMO-8400 was additive to the effect on gene expression that was
observed with IMO-3100.
IMO-3100 is a dual antagonist of TLR7 and TLR9.
Top-line Results of Phase 2 Trial of IMO-3100 in Patients with Psoriasis
Announced
In December 2012, the Company announced top-line results from a Phase 2 trial
of IMO-3100 in patients with moderate to severe plaque psoriasis. The Company
expects that full data from this trial will be presented at the International
Investigative Dermatology meeting in May 2013.
In this double-blind, placebo-controlled trial, 44 patients were randomized on
a 1:1:1 basis to receive IMO-3100 monotherapy at 0.16 or 0.32 mg/kg or placebo
by subcutaneous injection once weekly for four weeks with four weeks of
follow-up. Assessments of safety and multiple parameters of clinical activity,
including PASI score, were monitored throughout the study. In addition to the
clinical assessments, biopsies of psoriasis plaques were evaluated for
treatment-related changes in epidermal thickness and immune cell infiltrates
consistent with the intended mechanism of action.
Previously announced top-line clinical results from this trial include:
*Treatment at both IMO-3100 dose levels was well tolerated, with no
treatment-related discontinuations
*A treatment effect was demonstrated in measures of clinical efficacy in
patients in both IMO-3100 dose cohorts and PASI reductions at both dose
levels were sustained throughout the four-week follow-up period
*At the end of the four-week follow-up period, 48% of patients treated with
either dose of IMO-3100 (12 of 25) demonstrated improvements of 35% to 90%
from baseline PASI scores compared with 0 of 12 in the placebo cohort;
this difference was statistically significant (p<0.005)
*The trial achieved the pre-specified clinical endpoint of reduction in
PASI scores at the end of treatment in the 0.16-mg/kg dose cohort with
statistical significance (p<0.02) compared to the placebo cohort, but not
in the 0.32-mg/kg dose cohort
*The 0.16-mg/kg cohort also achieved, with statistical significance
(p<0.02), the pre-specified clinical endpoint of improvement in plaque
induration, a measure of plaque thickness, at the end of treatment and
during the follow-up period
*At the end of the four-week follow-up period, 25% (3 of 12) of patients
treated with 0.16 mg/kg/dose and 31% (4 of 13) with 0.32 mg/kg/dose
achieved PASI 50 or greater, compared to 0 of 12 placebo patients
Skin biopsies were collected at baseline and after completion of treatment to
investigate changes in epidermal thickness and immune cell infiltrates. Change
in epidermal thickness was the primary endpoint for the trial. Placebo-treated
patients had a median change in epidermal thickness of +7.7% compared to a
median change of -6.4% among IMO-3100 treated patients; this difference was
not statistically significant and the primary endpoint of the trial was not
achieved. A known limitation of skin biopsies after four weeks of treatment is
that psoriatic plaques do not resolve in a uniform fashion, and therefore,
biopsies may not provide a representative sampling of lesions (ref: Ann Rheum
Dis 2005;64:65-68).
Partnered Programs
TLR7, TLR 8 and TLR9 Agonists as Vaccine Adjuvants
Idera and Merck & Co., Inc. entered into an exclusive license and research
collaboration agreement in December 2006 to research, develop and
commercialize vaccine products containing the Company's TLR7, TLR8 and TLR9
agonists in the fields of oncology, infectious diseases and Alzheimer's
disease.
*In the first quarter of 2012, Merck selected several novel agonists
targeted to TLR7, TLR8 or TLR9 for evaluation and exclusive use as vaccine
adjuvant candidates under the companies' collaboration and license
agreement.
Additional Proprietary Programs
The Company is seeking to enter into collaborations with third parties to
advance its clinical programs in oncology and respiratory diseases and
research programs in hematologic malignancies, use of TLR3 agonists as vaccine
adjuvants, and applications of gene-silencing Oligonucleotide technology.
Intellectual Property
In2012, the Company was issued22new U.S. and foreign patents related to its
TLR-targeted compounds. Presently, the Company's intellectual property
portfolio contains over400 patents and patent applications worldwide,
including over200patents and patent applications covering the Company's
TLR-targeted compounds. In addition, the Company's intellectual property
portfolio includes more than150patents and patent applications for antisense
technology and10patents andpatent applications for GSO technology.
Financing
In November 2012, Idera raised $7.0 million in gross proceeds in a convertible
preferred stock and warrant offering. In the offering, the Company issued and
sold 424,242 shares of its Series E convertible preferred stock (convertible
into 8,484,840 shares of common stock) and warrants to purchase 8,484,840
shares of common stock.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is developing a novel approach to the treatment of
autoimmune and inflammatory diseases by targeting specific Toll-like Receptors
(TLRs) to inhibit the induction of immune responses. The Company has two drug
candidates in clinical development: IMO-8400, an antagonist of TLRs 7, 8 and
9, and IMO-3100, an antagonist of TLR7 and 9. Additionally, Idera has a
collaboration with Merck & Co. for the use of TLR agonists as vaccine
adjuvants for cancer, infectious diseases and Alzheimer’s disease. For more
information, visit http://www.iderapharma.com
Idera Forward Looking Statements
This press release contains forward-looking statements concerning Idera
Pharmaceuticals, Inc. that involve a number of risks and uncertainties. For
this purpose, any statements contained herein that are not statements of
historical fact may be deemed to be forward-looking statements. Without
limiting the foregoing, the words "believes," "anticipates," "plans,"
"expects," "estimates," "intends," "should," "could," "will," "may," and
similar expressions are intended to identify forward-looking statements. There
are a number of important factors that could cause Idera's actual results to
differ materially from those indicated by such forward-looking statements,
including whether Idera will be able to obtain cash resources sufficient to
fund the Company's operations; whether results obtained in preclinical studies
and early clinical trials such as the studies and trials referred to in this
release will be indicative of results obtained in future clinical trials;
whether Idera’s clinical trials will commence and will be completed when
expected by Idera; whether products based on Idera's technology will advance
into or through the clinical trial process on a timely basis or at all and
receive approval from the United States Food and Drug Administration or
equivalent foreign regulatory agencies; whether, if the Company's products
receive approval, they will be successfully distributed and marketed; whether
the Company's collaboration with Merck & Co, Inc., will be successful; whether
the patents and patent applications owned or licensed by the Company will
protect the Company's technology and prevent others from infringing it; and
such other important factors as are set forth under the caption "Risk Factors"
in Idera's Annual Report on Form 10-K for the year ended December 31, 2012
which important factors are incorporated herein by reference. Idera disclaims
any intention or obligation to update any forward-looking statements.
Idera Pharmaceuticals, Inc.
Condensed Statements of Operations
(In thousands, except per share data)
Three Months Ended Year Ended
December 31, December 31,
2012 2011 2012 2011
(Unaudited)
Revenues $ 11 $ 8 $ 51 $ 53
Operating
Expenses
Research & 3,078 5,700 13,673 17,969
Development
General & 1,265 1,539 6,279 7,939
Administrative
Total
Operating 4,343 7,239 19,952 25,908
Expenses
Loss from (4,332 ) (7,231 ) (19,901 ) (25,855 )
Operations
Decrease in
Fair Value of 569 1,974 675 1,974
Warrant
Liability
Other, net (35 ) 97 (14 ) 105
Net Loss (3,798 ) (5,160 ) (19,240 ) (23,776 )
Preferred
Stock 2,730 4,548 3,210 4,548
Accretion and
Dividends
Net Loss
Applicable to $ (6,528 ) $ (9,708 ) $ (22,450 ) $ (28,324 )
Common
Stockholders
Basic and
Diluted Net
Loss Per
Common Share $ (0.24 ) $ (0.35 ) $ (0.81 ) $ (1.03 )
Applicable to
Common
Stockholders
Shares Used in
Computing
Basic and
Diluted Net
Loss Per 27,642 27,635 27,639 27,623
Common Share
Applicable to
Common
Stockholders
Idera Pharmaceuticals, Inc.
Condensed Balance Sheet Data
(In thousands)
At December 31,
2012 2011
Cash & Cash Equivalents $ 10,096 $ 24,571
Other Assets 727 1,024
Total Assets $ 10,823 $ 25,595
Total Liabilities $ 4,196 $ 7,650
Redeemable Preferred Stock 5,921 5,921
Stockholders' Equity 706 12,024
Total Liabilities, Redeemable Preferred
Stock & Stockholders' Equity $ 10,823 $ 25,595
Contact:
Idera Pharmaceuticals, Inc.
Lou Arcudi, 617-679-5517
larcudi@iderapharma.com